The following data is part of a premarket notification filed by Gebauer Company with the FDA for Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (mist Spray And Medium Spray).
| Device ID | K172028 |
| 510k Number | K172028 |
| Device Name: | Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray And Medium Spray) |
| Classification | Refrigerant, Topical (vapocoolant) |
| Applicant | Gebauer Company 4444 East 153rd Street Cleveland, OH 44128 |
| Contact | Brittney Schmies |
| Correspondent | Brittney Schmies Gebauer Company 4444 East 153rd Street Cleveland, OH 44128 |
| Product Code | MLY |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-05 |
| Decision Date | 2017-10-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30303860008041 | K172028 | 000 |
| 20303860008037 | K172028 | 000 |
| 20303860008020 | K172028 | 000 |
| 30303860008010 | K172028 | 000 |